Quantitative MRI and Outcomes of Liver Resection

NCT06181318 | Unknown DMC

• 1 other identifier: POLIVER20230628
• Study Type: observational
• Target: 33
• Locations: 0 countries
• Sites: N/A

Brief Summary

The present observational study aims to assess the benefit of this quantitative multiparametric magnetic resonance imaging (MRI) in clinical practice, to quantify future liver remnant performance, and to accurately predict the risk of liver failure after major hepatectomy, among patients undergoing major liver resection. The main questions to be answered are:

• Can multiparametric MRI predict the postoperative liver function?
• Can multiparametric MRI predict the postoperative liver-specific complications as well as mortality? With ethical approval and fully informed consent, patients being considered for major liver resection will undergo clinical assessment, blood sampling, and multiparametric MRI before surgery. For the primary outcome, 33 participants will be needed to detect a minimum correlation coefficient of 0.2 with 5% significance and 80% power.

Conditions

Liver Cancer; Liver Failure; Bile Leak; Liver Metastases

Keywords

Liver surgery; Major hepatectomy; Posthepatectomy liver failure; Future liver remnant; quantitative multiparametric MRI

Outcome Measures

Primary Outcomes (3)

• Predicting the posthepatectomy liver failure after major liver resection

  Correlation between future liver remnant performance (combined measure of liver volume, PDFF, and cT1) and posthepatectomy liver failure after major liver resection

  90 days postoperative

• Predicting the posthepatectomy biliary leakage after major liver resection

  Correlation between future liver remnant performance (combined measure of liver volume, PDFF, and cT1) and posthepatectomy biliary leakage after major liver resection

  90 days postoperative

• Predicting the posthepatectomy hemorrhage after major liver resection

  Correlation between future liver remnant performance (combined measure of liver volume, PDFF, and cT1) and posthepatectomy hemorrhage after major liver resection

  90 days postoperative

Secondary Outcomes (2)

• Correlation between remnant liver function after major liver resection and incidence of major complications

  90 days postoperative

• Correlation between remnant liver function after major liver resection and postoperative mortality

  90 days postoperative

Study Arms (1)

Study group

Participants will be recruited after they have been diagnosed and their treatment has been planned by a multidisciplinary tumor board. Patients indicated to undergo major liver resection (\> 3 segments based on Brisbane classification \[23\]) will be eligible for participation.

Diagnostic Test: Multiparametric MRI scan of the liver

Interventions

Multiparametric MRI scan of the liver DIAGNOSTIC_TEST

MRI scans will be performed at the Champalimaud Foundation using a 1.5T scanner after patients have fasted for 4 hours. Transverse abdominal T1 maps will be acquired to estimate extracellular fluid (which increases in cases of fibrosis and inflammation) and T2\* maps will be acquired to estimate liver iron levels. These quantitative MRI maps will be laid onto the volumetric images of Couinaud segments. Multi-slice quantitative maps will be generated using Liver MultiScan software (Perspectum, UK) with operators blinded to patient status. T1 measurements will be adjusted for the iron level to give iron-corrected T1 maps (cT1). Reference ranges for cT1 have been defined in the general population. PDFF maps of the liver will be calculated using MRI multi-echo and spoiled-gradient-echo acquisition. No intravenous contrast agents will be used in Liver MultiScan maps and the total scan duration will be approximately 30 minutes.

Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited after they have been diagnosed and their treatment has been planned by a multidisciplinary tumor board. Patients indicated to undergo major liver resection (\> 3 segments based on Brisbane classification) will be eligible for participation. No change in treatment or intervention is proposed in the present study. All evaluations and analyses will take place at Champalimaud Clinical Centre. Patients who are being considered for major liver resection and have given informed consent will undergo a preoperative assessment, during which baseline clinical data and blood samples will be collected and a multiparametric MRI scan of the liver will be performed.

You may qualify if:

• Adult (≥ 18 years old) patients with an indication for elective major liver resection.
• Any benign or malignant indication.
• Provision of informed consent.
• MRI scan performed ≤ 7 days before surgery

You may not qualify if:

• Previous liver resection.
• Previous volume-enhancing procedures, such as portal vein embolization.
• Previous microwave ablation of liver lesions.
• Contraindication and/or inability to undergo contrast-enhanced MRI scan (including implanted metallic devices or foreign bodies, claustrophobia and contraindication for Primovist® administration).

Sponsors & Collaborators

• University Hospital Heidelberg: lead
• Fundacao Champalimaud: collaborator

MeSH Terms

Conditions

Liver Neoplasms; Liver Failure

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Hepatic Insufficiency

Central Study Contacts

Arianeb Mehrabi, Professor

CONTACT

004962215636223; arianeb.mehrabi@med.uni-heidelberg.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr. med.

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: December 26, 2023
• Study Start: February 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: April 30, 2025
• Last Updated: December 26, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF